This early study is testing a new device called the CI Percutaneous Ring Annuloplasty System. This system is designed to help people with moderate to severe functional tricuspid regurgitation (TR), a condition where a heart valve doesn't close properly. The study will look at how safe and effective it is to implant this ring and then adjust it about 90 days later. To join, you must be at least 18 years old and have moderate to severe TR, with a specific measurement of your tricuspid valve. The main goal is to see if participants are free from device or procedure-related death 30 days after the ring adjustment. The study is currently enrolling up to 15 participants.

Study design

This is an early, single-arm study, meaning all 15 participants will receive the CI Percutaneous Ring Annuloplasty System. It is not randomized, so there is no comparison group.

What's involved

You would undergo a procedure to implant the CI ring, followed by an adjustment procedure approximately 90 days later. The study will also assess changes in heart function and quality of life.

Compensation

Not stated in the trial record.

Follow-up

Participants will be followed for at least 30 days after the ring adjustment to check for device or procedure-related mortality.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.